Events

Recall of Device Recall AMT GJet LowProfile TransgastricJejunal Feeding Device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Applied Medical Technology Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73339
  • Event Risk Class
    Class 2
  • Event Number
    Z-1497-2016
  • Event Initiated Date
    2016-01-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144693
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Tubes, gastrointestinal (and accessories) - Product Code KNT
  • Reason
    The firm received complaints that the product is shorter in length than indicated on the label.
  • Action
    On 1/26/2016 the firm telephoned their customers notifying them of the recall. On 2/19/2016 the firm sent recall notification letters to their customers. The letter identified the product, problem, and actions to be taken by the customer.

Device

Device Recall AMT GJet LowProfile TransgastricJejunal Feeding Device
  • Model / Serial
    Model #GJ-1415-45, Lot # 15104750, Exp Date: 2018/09
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of AZ, CA, DE, IN, MI, NM, PA & VA.
  • Product Description
    AMT G-Jet¿ Low-Profile Transgastric-Jejunal Feeding Device 14F 1.5cm 45cm SINGLE USE ONLY Rx ONLY STERILE. || For use in patients who cannot absorb adequate nutrition through the stomach.
  • Manufacturer
    Applied Medical Technology Inc

Manufacturer

Applied Medical Technology Inc
  • Manufacturer Address
    Applied Medical Technology Inc, 8000 Katherine Blvd, Brecksville OH 44141-4202
  • Manufacturer Parent Company (2017)
    Applied Medical Technology Inc.
  • Source
    USFDA